Dublin-based medical device company Allergan Inc. was hit with a proposed class action lawsuit in Michigan federal court alleging the company “buried” reports of cancer associated with its now-recalled textured silicone breast implants instead of alerting federal authorities or consumers.
According to the lawsuit filed just two days before Thanksgiving, Allergan knew that its Biocell breast implants put women at a significant risk for a rare type of blood cancer known as breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL.
The company issued a global recall of the Biocell breast implants and tissue expanders in July, after the Food and Drug Administration (FDA) boldly asked the company to stop selling them in the U.S. due to the risk of BIA-ALCL. The FDA became aware of 573 reports of cancer worldwide in people who had received breast implants, including 33 deaths, of which 481 were Allergan implants. Among the 33 deaths, only 13 reported the type of implant used, and all but one implant was made by the company. The rare form of lymphoma develops in the tissue or capsule around the implant, and can take years to develop.
The women suing Allergan want the company to provide them with medical monitoring for BIA-ALCL and other breast implant-related diseases. And while their implants fall under a warranty that allows the women to undergo revision surgery to remove and replace their current implants with another Allergan implant, the company refuses to pay for the surgery or any of the associated costs with revision surgery.
“As is clear from its post-recall conduct and representations, Allergan has failed to – and has no plans to – provide medical monitoring for plaintiffs and the class members due to the increased risk of developing BIA-ALCL from the recalled Biocell implants,” the lawsuit states.
Since the breast implant recall, Allergan has been hit with numerous lawsuits.